NCT00260936CompletedNot Applicable
Prevalence of Morphologic and Metabolic Anormalities in HIV Infected and Uninfected Young Men
University of North Carolina, Chapel Hill13 sites in 2 countries250 target enrollmentStarted: March 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 250
- Locations
- 13
Study Overview
Brief Summary
To assess whether there exist significant differences in glucose metabolism, lipids, lactate, body composition, and bone density between HIV-infected and uninfected young men.
Detailed Description
The study involves a one-time collection of health and medical history data, blood and urine specimens, and physical assessments. This study will elucidate the need for a further in-depth study to understand the pathophysiological effects of protease inhibitor (PI)-based and non-nucleoside analogue reverse transcriptase inhibitor (NNRTI)-based therapies in young men.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 12 Years to 24 Years (Child, Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Males age 12 years and 0 days through 24 years and 364 days.
- •Tanner stage 4 or
- •Accessible medical history and medications history.
- •Willingness to fast and complete all clinical evaluations and specimen collection.
- •Willingness and ability to give informed consent or assent with parental/legal guardian permission, where required.
- •Group 1: HIV-Negative Control Subject Specific Inclusion Criteria
- •All subjects for Group 1 will be tested for HIV-1 to confirm negativity unless they have a documented negative antibody test within the last three months of study entry.
- •Willingness and ability to give informed consent for HIV testing. Groups 2, 3, and 4: HIV-Positive Subject Specific Inclusion Criteria
- •HIV-1 infection as documented by a positive result on any of the following licensed tests at any time: any antibody test confirmed by Western blot, HIV culture, plasma HIV-1 RNA PCR >1,000 copies/ml or HIV-1 DNA PCR.
- •Horizontal HIV infection transmission (non-perinatal, non-transfusion acquired infection).
- •Group 2: Currently not on ART and must never have received ART.
- •Group 3: Currently on a NNRTI, non-PI containing regimen for three or more months, must never have received a total of more than six months of PI-containing regimen and at least one year must have passed since receipt of last PI-containing regimen.
- •Group 4: Currently on a PI, non-NNRTI containing regimen for three or more months, must never have received a total of more than six months of NNRTI-containing regimen and at least one year must have passed since receipt of last NNRTI-containing regimen.
Exclusion Criteria
- •Transgender male to female (MTF) or female to male (FTM) youth
- •Refusal to fast for the 8 hours before collection of laboratory specimen requiring fasting.
- •Unable to obtain medical/medications history.
- •History of anorexia or bulimia.
- •Type I Diabetes Mellitus.
- •Type II Diabetes Mellitus and cannot omit diabetes medication for the 48-hour period prior to laboratory specimen collection for oral glucose tolerance test (OGTT).
- •Current use or use within the past 6 months of oxandrolone, nandrolone, oxymetholone, stanozolol, or any other synthetic anabolic/androgenic agents.
- •Current use or use within the past 6 months of pharmacologic doses of growth hormone. Physiologic growth hormone replacement therapy is permitted, as long as dosages meet the following specifications:
- •Adolescents in puberty - less than or equal to an equivalent of 0.1 mg/kg/day
- •Adolescents past puberty - less than or equal to an equivalent of 0.025 mg/kg/day
- •Current use or use within the past 6 months of pharmacologic doses of testosterone. Physiologic testosterone replacement therapy is permitted as long as dosages meet the following specifications:
- •Injection - no more than 400 mg/month of testosterone enanthate
- •Patch - no more than 5 mg/day (e.g. Testoderm, Androderm)
- •Gel in pre-packaged doses - no more than 7.5 g/day of gel (e.g. Androgel, Testim)
Investigators
Study Sites (13)
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